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Baxter Healthcare Corporation: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with pus

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.
Reason / hazard
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Taiwan and Uruguay.
Recall initiated
2026-04-22
Code info
Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806
Product quantity
105675
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
98852
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